Leaving the EU with a deal remains the Government’s top priority. This has not changed. However a responsible government must plan for every eventuality, including a no deal scenario.
Contingency legislation is needed in order for the Medicines and Healthcare products Regulatory Agency (MHRA) to be able to take on regulatory processes for human medicines and devices that are currently undertaken by the European Medicines Agency and other bodies.
The three separate pieces of legislation will allow for the continued sale of, and access to, medicines, medical devices and clinical trials:
- Human Medicines Regulations 2012, as amended by the Human Medicines (Amendment etc) (EU Exit) Regulations 2019
- The Medical Devices (amendment) (EU exit) Regulations 2019
- The Medicines for Human Use (Clinical Trials) (amendment) (EU exit) Regulations 2019
These Regulations have been approved by Parliament and were made in April 2019.
The Human Medicines and Medical Devices (Amendment etc.) (EU exit) Regulations 2019 have been laid in parliament today (24 July 2019).
This instrument makes a number of changes to the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 and the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 to ensure that the UK legislation accurately reflects technical updates at EU level since April 2019 and also corrects drafting errors and omissions to reflect published policy in the event of a no deal Brexit.
Full details of the changes are set out in the explanatory memorandum.
The legislation will be subject to parliamentary scrutiny and approval which we anticipate in the autumn.